DRUG DESCRIPTION

Pemetrexed disodium heptahydrate has the chemical name L-Glutamic
acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H?­pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-,
disodium salt, heptahydrate. It is a white to almost-white solid with a molecular
formula of C20H19N5Na2O6•7H2O
and a molecular weight of 597.49. The structural formula is as follows:

ALIMTA is supplied as a sterile lyophilized powder for intravenous infusion
available in single-dose vials. The product is a white to either light yellow
or green-yellow lyophilized solid. Each 100-mg or 500-mg vial of ALIMTA contains
pemetrexed disodium equivalent to 100 mg pemetrexed and 106 mg mannitol or 500
mg pemetrexed and 500 mg mannitol, respectively. Hydrochloric acid and/or sodium
hydroxide may have been added to adjust pH.

What are the possible side effects of pemetrexed (Alimta)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

pale skin, easy bruising or bleeding, unusual weakness;

fever, chills, body aches, flu symptoms;

white patches or sores inside your mouth or on your lips;

urinating less than usual, or not at all;

chest pain, trouble breathing;

swelling,...

Read All Potential Side Effects and See Pictures of Alimta »

What are the precautions when taking pemetrexed (Alimta)?

Before using pemetrexed, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who...

Read All Potential Precautions of Alimta »

Alimta Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, loss of appetite, constipation, diarrhea, mouth sores, headache, body aches/pains, dizziness, and tiredness may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be needed to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, new or worsening shortness of breath.

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Pemetrexed can commonly cause a rash that is usually not serious and that can be prevented by taking corticosteroid medication (see How to Use section). However, if you do develop a rash, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop a rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using pemetrexed, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

Wash your hands well to prevent the spread of infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is not recommended for use during pregnancy. It may cause harm to an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use two effective forms of birth control (e.g., condoms, birth control pills) while using this medication and for some period afterwards.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Alimta Patient Information Including Side Effects

Brand Names: Alimta

Generic Name: pemetrexed (Pronunciation: pem e TREX ed)

What is pemetrexed (Alimta)?

What are the possible side effects of pemetrexed (Alimta)?

What is the most important information I should know about pemetrexed (Alimta)?

What should I discuss with my healthcare provider before receiving pemetrexed (Alimta)?

How is pemetrexed given (Alimta)?

What happens if I miss a dose (Alimta)?

What happens if I overdose (Alimta)?

What should I avoid while receiving pemetrexed (Alimta)?

What other drugs will affect pemetrexed (Alimta)?

Where can I get more information?

What is pemetrexed (Alimta)?

Pemetrexed is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Pemetrexed is used to treat mesothelioma, a form of lung cancer associated with exposure to asbestos. Pemetrexed is also used to treat non-small cell lung cancer that has already been treated with other cancer medications.

Pemetrexed may also be used for other purposes not listed in this medication guide.

What are the possible side effects of pemetrexed (Alimta)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pemetrexed (Alimta)?

Before receiving pemetrexed, tell your doctor if you are allergic to any drugs, or if you have kidney or liver disease, bone marrow suppression, a weak immune system, or excess fluid in the space around your lung, liver, or other internal organs.

Throughout your treatment with pemetrexed, you will need to take folic acid and vitamin B-12 to protect your stomach, blood cells, and bone marrow from the side effects of pemetrexed. You will need to start taking these supplements a week before receiving your first pemetrexed infusion, and will keep taking them for 3 weeks after your treatment ends.

Vitamin B-12 and folic acid are available over the counter. Be sure to take only the forms and strengths of these supplements that your doctor has recommended.

Pemetrexed is usually given every 3 weeks. Your doctor will determine how many treatment cycles you should receive.

Pemetrexed can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your cancer treatments may be delayed based on the results of these tests. Do not miss any scheduled visits to your doctor.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Before you receive pemetrexed, tell your doctor if you are taking an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), indomethacin (Indocin), ketoprofen (Orudis), and others.